Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Reported: May 4, 2022 Initiated: February 21, 2022 #Z-1017-2022
Product Description
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Reason for Recall
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Details
- Recalling Firm
- Freudenberg Medical, Llc
- Units Affected
- 8 units (OUS)
- Distribution
- US distribution: GA, OH Foreign distribution: Netherlands
- Location
- Jeffersonville, IN
Frequently Asked Questions
What product was recalled? ▼
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS). Recalled by Freudenberg Medical, Llc. Units affected: 8 units (OUS).
Why was this product recalled? ▼
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2022. Severity: Moderate. Recall number: Z-1017-2022.
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